Intestine dysfunction treatment apparatus

ABSTRACT

An intestine dysfunction treatment apparatus comprises an electric stimulation device ( 56 ) implanted in a patient, who suffers from intestine dysfunction. The stimulation device comprises electric conductors adapted to directly engage with a muscle that directly or indirectly affects the transportation of the content of the patient&#39;s intestines, for example the anal sphincter ( 58 ) or a portion of the muscle that contracts the bowels, to electrically stimulate the muscle to increase the tonus thereof. A control device ( 62 ) is provided for controlling a source of energy ( 64 ), which may or may not be implanted, to release electric energy for use in connection with the power of the stimulation device. The apparatus can be used for treating patients suffering from anal incontinence or constipation.

The present invention relates to an intestine dysfunction treatmentapparatus, comprising an electric stimulation device implantable in apatient, who suffers from intestine dysfunction. (The term “patient”includes an animal or a human being.)

Intestine dysfunction may involve disability of controlling the musclethat contracts the bowels, colon or rectum to provide transportation ofthe content thereof. Such a disability usually causes constipation. Inparticular paralysed patients may suffer from constipation. Furthermore,intestine dysfunction may involve anal incontinence, i.e disability toclose the anal sphincter.

Anal incontinence is a widespread disease. Several kinds of sphincterplastic surgery are used today to remedy anal incontinence. There is aprior manually operated sphincter system in an initial clinical trialphase where a hydraulic sphincter system connected to an elasticreservoir (balloon) placed in the scrotum is developed. A disadvantageof this system is that thick, hard fibrosis is created around thereservoir by pump movements making the system useless sooner or later.Another disadvantage is that the use of hydraulic fluid always entails arisk of fluid leaking from the implanted hydraulic system.

Furthermore, it is a rather complicated task to manually pump thereservoir when defecation is needed. U.S. Pat. No. 5,593,443 discloseshydraulic anal sphincter under both reflex and voluntary control. Aninflatable artificial sphincter with the pump system in scrotum isdisclosed in U.S. Pat. No. 4,222,377.

U.S. Pat. No. 4,739,764 discloses a method for treating analincontinence by electric stimulation of nerves connected to musclescontrolling the anal sphincter. The function of the anal sphincter isaffected by applying electric pulse trains on the nerves.

The object of the present invention is to provide a new convenientintestine dysfunction treatment apparatus, the performance of which maybe affected by the patient at any time after operation, in particularwhen various needs arise over the course of a day, so that the patientsubstantially always is satisfied or comfortable.

This object is achieved by an intestine treatment apparatus of the kindstated initially characterised in that the stimulation device compriseselectric conductors adapted to directly engage with a muscle thatdirectly or indirectly affects the transportation of the content of thepatient's intestines, to electrically stimulate the muscle to increasethe tonus thereof.

As opposed to the prior art solution according to the above-noted U.S.Pat. No. 4,739,764, which requires complicated surgery to identify therelevant nerve or nerves and application of electrodes thereto, theapparatus of the present invention is easy and foolproof to implant.Accordingly, the surgeon can easily engage the electric conductors withthe muscle in question without need for identifying specific nerves.

Muscles that directly affect the transportation of the content of thepatient's intestines include the anal sphincter and muscles that arecapable of contracting the intestines, i.e. the wall muscle of theintestines. A muscle that indirectly affects the transportation of thecontent of the patient's intestines may be the rectus abdominis of apatient who has iliostomy, jejunostomy, colostomy or rectostomy. Forexample, in a colostomy patient a portion of the colon is pulled throughthe rectus abdominis, which means that when stimulated the rectusabdominis can function as an anal sphincter. Any of these muscles may beselected for engagement with the stimulation device of the invention.

The apparatus preferably comprises a source of energy and a controldevice controllable from outside the patient's body for controlling thesource of energy to release energy for use in connection with the powerof the stimulation device, when the stimulation device is implanted. Asa result, the apparatus of the invention provides a simple and effectivecontrol of the energy supplied to implanted components of the apparatuswhich ensures an extended and reliable functionality of the apparatus,possibly for the rest of the patient's life and at least many years.

An important problem is that the voltage intensity strong enough toprovide the desired stimulation of the anal sphincter might fade overtime, due to increasing electric resistance caused by the formation offibrosis where the conductors engage the anal sphincter. This problem issolved by a main embodiment of the present invention, in which theelectric source of energy provides a current through the electricconductors. More particularly, the control device is adapted to controlthe electric source of energy to release electric energy such that theintensity of the current through the electric conductors amounts to apredetermined value. As a result, decreasing current intensity caused bythe formation of fibrosis where the conductors engage the anal sphinctercan be compensated for. Thus, if the current through the conductorsdecreases the control device automatically controls the electric sourceof energy to release more electric energy to restore the desired currentintensity.

Advantageously, the control device is adapted to control the electricsource of energy to release energy in the form of an alternatingcurrent. The inventor has found that unlike an alternating current adirect current could cause electrolysis in the muscle. Such electrolysiscould injure the muscle.

The control device may also control the stimulation device.

Where the selected muscle comprises the anal sphincter, the patient isenabled to keep the anal sphincter completely closed by means of thestimulation device by using the control device whenever he likes duringthe day. Normally, the stimulation device is always powered except whenthe patient wants to defecate.

In accordance with a preferred embodiment of the invention, the sourceof energy comprises an electric source of energy and the control deviceis adapted to supply the stimulation device with electric energy fromthe electric source of energy. In the preferred embodiment, the controldevice is adapted to control the stimulation device to vary theintensity of the electric stimulation of the selected muscle over time.Preferably, the control device is controllable from outside thepatient's body to control the stimulation device to change the intensityof the electric stimulation of the muscle so that the muscle tonus ischanged.

Where the selected muscle comprises the anal sphincter, the controldevice is adapted to continuously supply the stimulation device withelectric energy from the electric source of energy to keep the analsphincter closed, except when the patient wants to defecate. The controldevice may be controllable by the patient to control the stimulationdevice to increase the intensity of the electric stimulation of the analsphincter so that the tonus of the anal sphincter is increased, when thepatient feels rectum contractions. Furthermore, the control device maybe controllable by the patient to control the stimulation device tocease supplying the stimulation device with electric energy when thepatient wants to defecate, and to decrease the intensity of the electricstimulation of the anal sphincter so that the tonus of the analsphincter is decreased, when the patient wants to release gas from therectum.

Where the selected muscle comprises the rectus abdominis of a patientwho has iliostomy, jejunostomy, colostomy or rectostomy, the controldevice may be adapted to continuously supply the stimulation device withelectric energy from the electric source of energy to stimulate therectus abdominis, except when the patient wants to defecate.

Where the selected muscle comprises the wall muscle of the intestines ofa patient who has iliostomy, jejunostomy, colostomy or rectostomy, thecontrol device may be adapted to continuously supply the stimulationdevice with electric energy from the electric source of energy tostimulate the wall muscle of the intestines to close the intestines,except when the patient wants to defecate.

Where the selected muscle is capable of contracting the patient's largebowel in a wave-like manner for transporting the faeces therein, thecontrol device is adapted to control the electric source of energy tomomentarily supply the stimulation device with electric energy to causethe muscle to momentarily contract the bowel in said wave-like manner.Advantageously, the control device is controllable by the patient topower the stimulation device to cause the muscle to contract the largebowel in said wave-like manner, in order to avoid constipation.

All of the embodiments of the present invention may be combined with atleast one implantable sensor for sensing at least one physical parameterof the patient. Where the selected muscle comprises the anal sphincterthe sensor may be adapted to sense as the physical parameter thepressure against the anal sphincter exerted by the faecal passageway. Tomake sure that the anal sphincter is safely closed when the patient'srectum is contracted, the electric stimulation device suitably isadapted to increase the stimulation intensity on the anal sphincter inresponse to the sensor sensing an abrupt increase in pressure caused byrectum contraction. As a result, the anal sphincter is kept firmlyclosed so that involuntary rectum contraction will not give rise toincontinence. Alternatively, the sensor may be adapted to sense as thephysical parameter the patient's orientation, and the electricstimulation device may be adapted to decrease the stimulation intensityon the anal sphincter in response to the sensor sensing that the patientis lying.

The sensor may comprise a pressure sensor for directly or indirectlysensing the pressure in the faecal passageway. The expression“indirectly sensing the pressure in the faecal passageway” should beunderstood to encompass the cases where the sensor senses the pressureagainst the stimulation device or human tissue of the patient.

The control device may comprise an internal control unit to be implantedin the patient. The internal control unit may suitably directly controlthe stimulation device in response to signals from the sensor. Inresponse to signals from the sensor, for example pressure, the patient'sposition, faecal passageway contraction or any other important physicalparameter, the internal control unit may send information thereon tooutside the patient's body. The internal control unit may alsoautomatically control the stimulation device in response to signals fromthe sensor. For example, where the selected muscle is the analsphincter, depending on the different needs of the individual patientsthe internal control unit may control the stimulation device either toefficiently stimulate the anal sphincter, so that the anal sphincter forcertain is completely closed, or to reduce the stimulation, in responseto the sensor sensing that the patient is lying.

The control device may also, or alternatively, comprise an externalcontrol unit outside the patient's body. The external control unit may,suitably directly, control the stimulation device in response to signalsfrom the sensor. The external control unit may store information on thephysical parameter sensed by the sensor and may be manually operated tocontrol the stimulation device based on the stored information. Inaddition, there may be at least one implantable sender for sendinginformation on the physical parameter sensed by the sensor.

Where the control device comprises an internal control unit, preferablyincluding a microprocessor, and an external control unit outside thepatient's body, the internal control unit may be programmable by theexternal control unit, for example for controlling the stimulationdevice over time. Alternatively, the internal control unit may controlthe stimulation device over time in accordance with an activity scheduleprogram, which may be adapted to the patient's needs.

Conveniently, the external control unit may load the internal controlunit with data in accordance with a loading mode only authorised for adoctor. For specialised controls of the stimulation device, such aselectric power, electric pulse frequency etc, the external control unitmay control the internal control unit in accordance with a doctor modeonly authorised for the doctor. For simple controls of the stimulationdevice, such as on and off, the external control unit may control theinternal control unit in accordance with a patient mode permitted forthe patient. Thus, by using the external control unit in accordance withdifferent modes it is possible to have certain functions of thestimulation device controlled by the patient and other more advancedfunctions controlled by the doctor, which enables a flexiblepost-operation treatment of the patient.

The control device may be adapted to control the source of energy torelease energy, for instance to intermittently release energy in theform of a train of energy pulses, for direct use in connection with thepower of the stimulation device. In accordance with a suitableembodiment the control device controls the source of energy to releaseelectric energy, and the apparatus further comprises an implantablecapacitor for producing the train of energy pulses from the releasedenergy. In this case the term “direct” is used to mean, on one hand,that the released energy is used while it is being released by thecontrol device, on the other hand, that the released energy may besomewhat delayed, in the order of seconds, by for instance an energystabiliser before being used in connection with the power of thestimulation device.

In accordance with an embodiment of the invention, the apparatuscomprises implantable electrical components including at least one, oronly one single voltage level guard and a capacitor or accumulator,wherein the charge and discharge of the capacitor or accumulator iscontrolled by use of the voltage level guard.

In accordance with a first main aspect of the invention, the source ofenergy is external to the patient's body and the control device controlsthe source of energy to release wireless energy. An additional source ofenergy may be implanted in the patient, wherein the implanted source ofenergy is activated by wireless energy released from the external sourceof energy, to supply energy, which is used in connection with the powerof the stimulation device.

Alternatively, an energy storage device, preferably an electricaccumulator, may be implanted in the patient for storing the wirelessenergy released from the external source of energy. The electricaccumulator may comprise at least one capacitor or at least onerechargeable battery, or a combination of at least one capacitor and atleast one rechargeable battery. Alternatively, a battery may beimplanted in the patient for supplying electric energy to implantedelectric energy consuming components of the apparatus, in addition tothe supply of wireless energy. Where the control device comprises animplantable control unit the electronic circuit thereof and thestimulation device may be directly powered with transformed wirelessenergy, or energy from either the implanted energy storage device orbattery.

In accordance with a second main aspect of the invention, the wirelessenergy is directly used for the power of the stimulation device, i.e.the stimulation device is powered as the wireless energy is releasedfrom the external source of energy by the control device. In this casethe term “directly” is used to mean, on one hand, that the stimulationdevice is promptly powered by using the released energy whiteout firststoring the latter, on the other hand, that the released energy may besomewhat delayed, in the order of seconds, by for instance an energystabiliser before being used for the power of the stimulation device. Asa result, a very simple control of the stimulation device is achievedand there are only a few implanted components of the apparatus. Forexample, there is no implanted source of energy, such as a battery, norany implanted complicated signal control system. This gives theadvantage that the apparatus will be extremely reliable.

In accordance with a third main aspect of the invention, the source ofenergy comprises an implantable internal source of energy. Thus, whenthe internal source of energy is implanted in a patient the controldevice controls it from outside the patient's body to release energy.This solution is advantageous for sophisticated embodiments of theapparatus that have a relatively high consumption of energy that cannotbe satisfied by direct supply of wireless energy.

The internal source of energy preferably comprises an electric source ofenergy, such as an accumulator or a battery.

In accordance with a fourth main aspect of the invention, the apparatuscomprises a switch implanted in the patient for directly or indirectlyswitching the power of the stimulation device and an internal electricsource of energy, such as a battery, implanted in the patient forsupplying electric energy for the power of the stimulation device,wherein the switch directly or indirectly affects the supply of electricenergy from the internal electric source of energy. This solution isadvantageous for embodiments of the apparatus that have a relativelyhigh consumption of energy that cannot be met by direct supply ofwireless energy.

In a first particular embodiment in accordance with the fourth mainaspect of the invention, the switch switches between an off mode, inwhich the internal electric source of energy is not in use, and an onmode, in which the internal electric source of energy supplies electricenergy for the power of the stimulation device. In this case, the switchis conveniently operated by the wireless energy released from theexternal source of energy to switch between the on and off modes. Thecontrol device, preferably comprising a wireless remote control, maycontrol the external source of energy to release the wireless energy.The advantage of this embodiment is that the lifetime of the implantedelectric source of energy, such as a battery, can be significantlyprolonged, since the implanted source of energy does not supply energywhen the switch is in its off mode.

In a second particular embodiment in accordance with the fourth mainaspect of the invention, the control device comprises a wireless remotecontrol for controlling the internal electric source of energy. In thiscase, the switch is operable by the wireless energy from the externalsource of energy to switch between an off mode, in which the internalelectric source of energy and remote control are not in use, and astandby mode, in which the remote control is permitted to control theinternal electric source of energy to supply electric energy for thepower of the stimulation device.

In a third particular embodiment in accordance with the fourth mainaspect of the invention, the apparatus further comprises an energytransforming device to be implanted in the patient for transforming thewireless energy into storable energy, and an implantable energy storagedevice for storing the storable energy, wherein the switch is operableby energy from the implanted energy storage device to switch between anoff mode, in which the internal electric source of energy is not in use,and an on mode, in which the internal electric source of energy supplieselectric energy for the power of the stimulation device. In this case,the control device suitably comprises a wireless remote control forcontrolling the energy storage device to operate the switch.

An external data communicator may be provided outside the patient's bodyand an internal data communicator to be implanted in the patient may beprovided for communicating with the external data communicator. Theinternal data communicator may feed data related to the patient, orrelated to the stimulation device, back to the external datacommunicator. Alternatively or in combination, the external datacommunicator may feed data to the internal data communicator. Theinternal data communicator may suitably feed data related to at leastone physical signal of the patient.

Suitably, an implantable stabiliser, such as a capacitor, a rechargeableaccumulator or the like, may be provided for stabilising the electricenergy released by the control device. In addition, the control devicemay control the source of energy to release energy for a determined timeperiod or in a determined number of energy pulses.

All of the above embodiments are preferably remote controlled. Thus, thecontrol device advantageously comprises a wireless remote controltransmitting at least one wireless control signal for controlling thestimulation device. With such a remote control it will be possible toadapt the function of the apparatus to the patient's need in a dailybasis, which is beneficial with respect to the treatment of the patient.

The wireless remote control may be capable of obtaining information onthe condition of the stimulation device and of controlling thestimulation device in response to the information. Also, The remotecontrol may be capable of sending information related to the stimulationdevice from inside the patient's body to the outside thereof.

In a particular embodiment of the invention, the wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver implantable in thepatient. In another particular embodiment of the invention, the wirelessremote control comprises at least one external signal receiver ortransceiver and at least one internal signal transmitter or transceiverimplantable in the patient.

The remote control may transmit a carrier signal for carrying thecontrol signal, wherein the carrier signal is frequency, amplitude orfrequency and amplitude modulated and is digital, analogue or digitaland analogue. Also the control signal used with the carrier signal maybe frequency, amplitude or frequency and amplitude modulated.

The control signal may comprise a wave signal, for example, a sound wavesignal, such as an ultrasound wave signal, an electromagnetic wavesignal, such as an infrared light signal, a visible light signal, anultra violet light signal, a laser signal, a micro wave signal, a radiowave signal, an x-ray radiation signal, or a gamma radiation signal.Where applicable, two or more of the above signals may be combined.

The control signal may be digital or analogue, and may comprise anelectric or magnetic field. Suitably, the wireless remote control maytransmit an electromagnetic carrier wave signal for carrying the digitalor analogue control signal. For example, use of an analogue carrier wavesignal carrying a digital control signal would give safe communication.The control signal may be transmitted in pulses by the wireless remotecontrol.

The control device may be activated in a manual or non-manual manner tocontrol the source of energy to release energy.

In the above-presented embodiments of the invention the released energymay comprise electric energy and an implantable capacitor having acapacity less than 0, 1 μF may be provided for producing theabove-mentioned train of energy pulses.

Generally, the wireless energy comprises a signal.

The apparatus may further comprise an implantable energy transformingdevice for transforming wireless energy, for example in the form ofsound waves, directly or indirectly into electric energy, for the powerof the stimulation device. More specifically, the energy transformingdevice may comprise a capacitor adapted to produce electric pulses fromthe transformed electric energy.

Generally, the stimulation device advantageously is embedded in a softor gel-like material, such as a silicone material having hardness lessthan 20 Shore.

The electric conductors may comprise hooks to secure the electricconductors on the muscle.

Where the selected muscle comprises the anal sphincter or extends arounda portion of the bowels or rectus abdominis, the stimulation devicesuitably comprises a band for application around the anal sphincter orthe portion of the bowels or rectus abdominis, wherein the band isprovided with the electric conductors for engaging the muscle. In thiscase, the electric conductors may also comprise the above-mentionedhooks.

All the above described various components may be combined in thedifferent embodiments where applicable. Also the various functionsdescribed in connection with the above embodiments of the invention maybe used in different applications, where applicable.

All the various ways of transferring energy and controlling the energypresented in the present specification may be practised by using all ofthe various components and solutions described.

The present invention also provides methods for treating intestinedysfunction.

Accordingly, in accordance with a first alternative method, there isprovided a method of treating intestine dysfunction, comprising thesteps of implanting an electric stimulation device in a patient, so thatthe stimulation device engages a muscle that directly or indirectlyaffects the transportation of the content of the patient's intestines,providing an electric source of energy, and controlling the electricsource of energy to power the stimulation device to electricallystimulate the muscle to increase the tonus thereof.

The first alternative method may also be performed laparascopically.Thus, there may be provided a laparascopic method of treating intestinedysfunction, comprising the steps of laparascopically implanting anelectric stimulation device in a patient, so that the stimulation deviceengages a muscle that directly or indirectly affects the transportationof the content of the patient's intestines, providing an electric sourceof energy, and controlling the electric source of energy to power thestimulation device to electrically stimulate the muscle to increase thetonus thereof.

In accordance with a second alternative method, there is provided amethod of treating a patient suffering from intestine dysfunction,comprising: (a) Surgically implanting in the patient an electricstimulation device engaging a muscle that directly or indirectly affectsthe transportation of the content of the patient's intestines. (b)Providing a source of energy external to the patient's body. (c)Controlling the external source of energy from outside the patient'sbody to release wireless energy. And (d) using the released wirelessenergy in connection with the powering of the stimulation device.

The second alternative method may further comprise implanting an energytransforming device, controlling the external source of energy torelease wireless energy, and transforming the wireless energy by theenergy transforming device into energy different from the wirelessenergy for use in connection with the power of the stimulation device.This method may further comprise implanting a stabiliser in the patientfor stabilising the energy transformed by the energy transformingdevice.

The invention is described in more detail in the following withreference to the accompanying drawings, in which

FIG. 1 is a schematic block diagram illustrating an embodiment of theintestine dysfunction treatment apparatus of the invention, in whichwireless energy is released from an external source of energy for use inthe power of a stimulation device;

FIG. 2 is a schematic block diagram illustrating another embodiment ofthe invention, in which wireless energy is released from an internalsource of energy;

FIGS. 3 to 6 are schematic block diagrams illustrating four embodiments,respectively, of the invention, in which a switch is implanted in thepatient for directly or indirectly switching the power of thestimulation device;

FIG. 7 is a schematic block diagram illustrating conceivablecombinations of implantable components for achieving variouscommunication options;

FIG. 8 illustrates the apparatus in accordance with the inventionimplanted in a patient; and

FIG. 9 is a block diagram illustrating remote control components of anembodiment of the invention.

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIG. 1 schematically shows an embodiment of the intestine dysfunctiontreatment apparatus of the invention having some parts implanted in apatient and other parts located outside the patient's body. Thus, inFIG. 1 all parts placed to the right of the patient's skin 2 areimplanted and all parts placed to the left of the skin 2 are locatedoutside the patient's body. The apparatus of FIG. 1 comprises animplanted electric stimulation device 4, which engages the muscle tissueof the patient's anal sphincter by means of electric conductors. Animplanted control unit 6 controls the stimulation device 4 via a controlline 8. An external control unit 10 includes an external source ofenergy and a wireless remote control transmitting a control signalgenerated by the external source of energy. The control signal isreceived by a signal receiver incorporated in the implanted control unit6, whereby the control unit 6 controls the implanted stimulation device4 in response to the control signal. The implanted control unit 6 alsouses electric energy drawn from the control signal for powering thestimulation device 4 via a power supply line 12.

FIG. 2 shows an embodiment of the invention identical to that of FIG. 1,except that an implanted internal electric source of energy in the formof a battery 42 is substituted for the external source of energy. Thus,an external control unit 40 without any source of energy is used in thisembodiment. In response to a control signal from the external controlunit 40 the implanted control unit 6 powers the stimulation device 4with energy from the battery 42.

FIG. 3 shows an embodiment of the invention comprising the stimulationdevice 4, the external control unit 10, and an implanted source ofenergy 236 and an implanted switch 238. The switch 238 is operated bywireless energy released from the external source of energy of theexternal control unit 6 to switch between an off mode, in which theimplanted source of energy 236 is not in use, and an on mode, in whichthe implanted source of energy 236 supplies energy for the power of thestimulation device 4.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 3,except that also the control unit 6 is implanted, in order to receive acontrol signal from the wireless remote control of the external controlunit 10. The switch 238 is operated by the wireless energy from theexternal source of energy 10 to switch between an off mode, in which theimplanted source of energy 236 and the wireless remote control of theexternal control unit 10 are not in use, i.e. the control unit 6 is notcapable of receiving the control signal, and a standby mode, in whichthe wireless remote control is permitted to control the internal sourceof energy 236, via the implanted control unit 6, to supply energy forthe power of the stimulation device 4.

FIG. 5 shows an embodiment of the invention identical to that of FIG. 4,except that an energy transforming device for transforming the wirelessenergy into storable energy is incorporated in the implanted controlunit 6 and that the implanted source of energy 236 is of a type that iscapable of storing the storable energy. In this case, in response to acontrol signal from the external control unit 10, the implanted controlunit 6 controls the switch 238 to switch from an off mode, in which theimplanted source of energy 236 is not in use, to an on mode, in whichthe source of energy 236 supplies energy for the power of thestimulation device 4.

FIG. 6 shows an embodiment of the invention identical to that of FIG. 5,except that an energy storage device 240 also is implanted in thepatient for storing the storable energy transformed from the wirelessenergy by the transforming device of the control unit 6. In this case,the implanted control unit 6 controls the energy storage device 240 tooperate the switch 238 to switch between an off mode, in which theimplanted source of energy 236 is not in use, and an on mode, in whichthe implanted source of energy 236 supplies energy for the power of thestimulation device 4.

FIG. 7 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communicationpossibilities. Basically, there are the implanted stimulation device 4,the implanted control unit 6 and the external control unit 10 includingthe external source of energy and the wireless remote control. Asalready described above the remote control transmits a control signalgenerated by the external source of energy, and the control signal isreceived by a signal receiver incorporated in the implanted control unit6, whereby the control unit 6 controls the implanted stimulation device4 in response to the control signal.

A sensor 54 may be implanted in the patient for sensing a physicalparameter of the patient, such as the pressure in the faecal passageway.The control unit 6, or alternatively the external control unit 10, maycontrol the stimulation device 4 in response to signals from the sensor54. A transceiver may be combined with the sensor 54 for sendinginformation on the sensed physical parameter to the external controlunit 10. The wireless remote control of the external control unit 10 maycomprise a signal transmitter or transceiver and the implanted controlunit 6 may comprise a signal receiver or transceiver. Alternatively, thewireless remote control of the external control unit 10 may comprise asignal receiver or transceiver and the implanted control unit 6 maycomprise a signal transmitter or transceiver. The above transceivers,transmitters and receivers may be used for sending information or datarelated to the stimulation device from inside the patient's body to theoutside thereof. For example, the battery 32 may be equipped with atransceiver for sending information on the charge condition of thebattery.

Those skilled in the art will realise that the above various embodimentsaccording to FIGS. 1-6 could be combined in many different ways.

FIG. 8 illustrates how any of the above-described embodiments of theanal incontinence treatment apparatus of the invention may be implantedin a patient. Thus, an assembly of the apparatus implanted in thepatient comprises a stimulation device in the form of a band 56, whichis wrapped around the anal sphincter 58. The band 58 is provided withconductors that engage the muscle tissue of the anal sphincter, so thatan electric connection is established between the conductors and themuscle tissue. An implanted control unit 60 is provided for controllingthe supply of electric energy to the band 56. There is an implantedenergy transforming device 62 for transforming wireless energy intoelectric energy. The transforming device 62 also includes a signalreceiver. An external control unit 64 includes a signal transmitter fortransmitting a control signal to the signal receiver of the implantedtransforming device 62. The transforming device 62 is capable oftransforming signal energy from the control signal into electric energyfor powering the stimulation device 56 and for energising other energyconsuming implanted components of the apparatus.

FIG. 9 shows the basic parts of a wireless remote control of theapparatus of the invention including an implanted electric stimulationdevice 4. In this case, the remote control is based on the transmissionof electromagnetic wave signals, often of high frequencies in the orderof 100 kHz-1 gHz, through the skin 130 of the patient. In FIG. 9, allparts placed to the left of the skin 130 are located outside thepatient's body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 is to be positioned close toa signal receiving antenna 134 implanted close to the skin 130. As analternative, the receiving antenna 134 may be placed for example insidethe abdomen of the patient. The receiving antenna 134 comprises a coil,approximately 1-100 mm, preferably 25 mm in diameter, wound with a verythin wire and tuned with a capacitor to a specific high frequency. Asmall coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas 132,134 to an implanted control unit 138. To avoid that accidental randomhigh frequency fields trigger control commands, digital signal codes areused. A conventional keypad placed on the external control unit 136 isconnected to the microprocessor thereof. The keypad is used to order themicroprocessor to send digital signals to either power or not power thestimulation device. The microprocessor starts a command by applying ahigh frequency signal on the antenna 132. After a short time, when thesignal has energised the implanted parts of the control system, commandsare sent to power the stimulation device. The commands are sent asdigital packets in the form illustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands may be sent continuously during a rather long time period.When a new power or non-power step is desired the Count byte isincreased by one to allow the implanted control unit 138 to decode andunderstand that another step is demanded by the external control unit136. If any part of the digital packet is erroneous, its content issimply ignored.

Through a line 140, an implanted energiser unit 126 draws energy fromthe high frequency electromagnetic wave signals received by thereceiving antenna 134. The energiser unit 126 stores the energy in apower supply, such as a large capacitor, powers the control unit 138 andpowers the electric stimulation device 4 via a line 142.

The control unit 138 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136. The microprocessor of the control unit 138 receives thedigital packet, decodes it and, provided that the power supply of theenergiser unit 126 has sufficient energy stored, powers the stimulationdevice 4 via a line 144.

Alternatively, the energy stored in the power supply of the energiserunit may only be used for powering a switch, and the energy for poweringthe stimulation device 4 may be obtained from another implanted powersource of relatively high capacity, for example a battery. In this casethe switch is adapted to connect said battery to the control unit 138 inan on mode when the switch is powered by the power supply and to keepthe battery disconnected from the control unit in a standby mode whenthe switch is not powered.

1. An intestine dysfunction treatment apparatus, comprising: an electricstimulation device implantable in a patient, who suffers from intestinedysfunction, electric conductors of the electric stimulation deviceadapted to directly engage with a muscle that directly or indirectlyaffects the transportation of the content of the patient's intestines,to electrically stimulate the muscle to increase the tonus thereof, aninternal electric source of energy implantable in the patient, and acontrol device controllable from outside the patient's body to controlthe internal electric source of energy to release electric energy foruse in connection with the power of the stimulation device, when thestimulation device is implanted, the electric energy being in the formof an alternating current through the electric conductors, the intensityof the current through the electric conductors amounting to apredetermined value, the control device automatically controlling theelectric source of energy to release more electric energy to restore thepredetermined value of current intensity when the current through theconductors decreases.
 2. An apparatus according to claim 1, wherein thecontrol device controls the stimulation device.
 3. An apparatusaccording to claim 2, wherein the control device controls thestimulation device to vary the intensity of the electric stimulation ofthe muscle over time.
 4. An apparatus according to claim 3, wherein thecontrol device is controllable from outside the patient's body tocontrol the stimulation device to change the intensity of the electricstimulation of the muscle so that the muscle tonus is changed.
 5. Anapparatus according to claim 4, wherein the muscle comprises the analsphincter, and the control device continuously supplies the stimulationdevice with electric energy from the electric source of energy to keepthe anal sphincter closed, except when the patient wants to defecate. 6.An apparatus according to claim 5, wherein the control device iscontrollable by the patient to control the stimulation device toincrease the intensity of the electric stimulation of the anal sphincterso that the tonus of the anal sphincter is increased, when the patientfeels rectum contractions.
 7. An apparatus according to claim 5, whereinthe control device is controllable by the patient to control thestimulation device to cease supplying the stimulation device withelectric energy when the patient wants to defecate.
 8. An apparatusaccording to claim 5, wherein the control device is controllable by thepatient to control the stimulation device to decrease the intensity ofthe electric stimulation of the anal sphincter so that the tonus of theanal sphincter is decreased, when the patient wants to release gas fromthe rectum.
 9. An apparatus according to claim 2, wherein the muscle iscapable of contracting the patient's large bowel in a wave-like mannerfor transporting the feces therein, and the control device controls theelectric source of energy to momentarily supply the stimulation devicewith electric energy to cause the muscle to momentarily contract thebowel in said wave-like manner.
 10. An apparatus according to claim 9,wherein the control device is controllable by the patient to power thestimulation device to cause the muscle to contract the large bowel insaid wave-like manner, in order to avoid constipation.
 11. An apparatusaccording to claim 2, wherein the control device comprises an internalcontrol unit implantable in the patient for controlling the stimulationdevice.
 12. An apparatus according to claim 11, wherein the internalcontrol unit is programmable.
 13. An apparatus according to claim 12,wherein the control device comprises an external control unit intendedto be outside the patient's body, the internal control unit beingprogrammable by the external control unit.
 14. An apparatus according toclaim 13, wherein the external control unit loads the internal controlunit with data in accordance with a loading mode only authorised for adoctor.
 15. An apparatus according to claim 13, wherein the externalcontrol unit controls the internal control unit in accordance with adoctor mode only authorised for a doctor.
 16. An apparatus according toclaim 13, wherein the external control unit controls the internalcontrol unit in accordance with a patient mode permitted for thepatient.
 17. An apparatus according to claim 12, wherein the internalcontrol unit is programmable for controlling the stimulation device overtime.
 18. An apparatus according to claim 17, wherein the internalcontrol unit controls the stimulation device over time in accordancewith an activity schedule program.
 19. An apparatus according to claim17, wherein the internal control unit comprises a microprocessor.
 20. Anapparatus according to claim 2, wherein the muscle comprises the rectusabdominis of the patient who has iliostomy, jejunostomy, colostomy orrectostomy therethrough, and the control device is adapted tocontinuously supply the stimulation device with electric energy from theelectric source of energy to stimulate the rectus abdominis to close thepatient's intestines, except when the patient wants to defecate.
 21. Anapparatus according to claim 2, wherein the muscle comprises the wallmuscle of the intestines of the patient who has iliostomy, jejunostomy,colostomy or rectostomy, and the control device is adapted tocontinuously supply the stimulation device with electric energy from theelectric source of energy to stimulate the wall muscle of the intestinesto close the intestines, except when the patient wants to defecate. 22.An apparatus according to claim 1, further comprising at least oneimplantable sensor for sensing at least one physical parameter of thepatient.
 23. An apparatus according to claim 22, wherein the musclecomprises the anal sphincter and the sensor senses as the physicalparameter the pressure against the anal sphincter exerted by the fecalpassageway.
 24. An apparatus according to claim 23, wherein the electricstimulation device increases the stimulation intensity on the analsphincter in response to the sensor sensing an abrupt increase inpressure caused by rectum contraction.
 25. An apparatus according toclaim 22, wherein the muscle comprises the anal sphincter and the sensorsenses as the physical parameter the patient's orientation.
 26. Anapparatus according to claim 25, wherein the electric stimulation devicedecreases the stimulation intensity on the anal sphincter in response tothe sensor sensing that the patient is lying down.
 27. An apparatusaccording to claim 22, wherein the sensor comprises a pressure sensorfor directly or indirectly sensing as the physical parameter thepressure in the fecal passageway of the patient.
 28. An apparatusaccording to claim 22, wherein the control device is controls thestimulation device in response to signals from the sensor.
 29. Anapparatus according to claim 28, wherein the control device comprises aninternal control unit implantable in the patient, the internal controlunit controlling the stimulation device in response to signals from thesensor.
 30. An apparatus according to claim 29, wherein the controldevice comprises an external control unit outside the patient's body,the external control unit controlling the stimulation device in responseto signals from the sensor.
 31. An apparatus according to claim 30,wherein the external control unit stores information on the physicalparameter sensed by the sensor and is manually operated to control thestimulation device based on the stored information.
 32. An apparatusaccording to claim 22, further comprising at least one implantablesender for sending information on the physical parameter sensed by thesensor.
 33. An apparatus according to claim 1, wherein the source ofenergy comprises an implantable internal electric source of energycomprising at least one accumulator, at least one capacitor or at leastone rechargeable battery, or a combination of at least one capacitor andat least one rechargeable battery.
 34. An apparatus according to claim1, further comprising a switch implantable in the patient for directlyor indirectly switching the power of the stimulation device.
 35. Anapparatus according to claim 34, wherein the switch directly orindirectly affects the supply of electric energy from the internalelectric source of energy.
 36. An apparatus according to claim 35,wherein the switch switches between an “off” mode, in which the internalelectric source of energy is not in use, and an “on” mode, in which theinternal electric source of energy supplies electric energy to thestimulation device.
 37. An apparatus according to claim 35, furthercomprising an energy transforming device implantable in the patient fortransforming the wireless energy into electric energy, which is storedby the internal electric source of energy.
 38. An apparatus according toclaim 37, wherein the switch switches from an “off” mode, in which theinternal electric source of energy is not in use, to an “on” mode, inwhich the internal source of electric energy supplies energy to thestimulation device.
 39. An apparatus according to claim 38, wherein thecontrol device controls the switch to switch between the “on” and “off”modes.
 40. An apparatus according to claim 39, wherein the controldevice comprises a wireless remote control.
 41. An apparatus accordingto claim 1, wherein the control device comprises a wireless remotecontrol.
 42. An apparatus according to claim 1, further comprising anexternal data communicator intended to be outside the patient's body,and an internal data communicator implantable in the patient forcommunicating with the external communicator, wherein the internal datacommunicator feeds data related to the patient back to the external datacommunicator or the external data communicator feeds data to theinternal data communicator.
 43. An apparatus according to claim 42,wherein the internal data communicator feeds data related to thestimulation device.
 44. An apparatus according to claim 42, wherein theinternal data communicator feeds data related to at least one physicalsignal of the patient.
 45. An apparatus according to claim 1, whereinthe control device comprises a wireless remote control for transmittingat least one wireless control signal for controlling the stimulationdevice.
 46. An apparatus according to claim 45, wherein the remotecontrol is capable of obtaining information on the condition of thestimulation device when the stimulation device is implanted and tocontrol the stimulation device in response to the information.
 47. Anapparatus according to claim 45, wherein the wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver implantable in thepatient.
 48. An apparatus according to claim 45, wherein the wirelessremote control comprises at least one external signal receiver ortransceiver and at least one internal signal transmitter or transceiverimplantable in the patient.
 49. An apparatus according to claim 45,wherein the remote control transmits a carrier signal for carrying thecontrol signal.
 50. An apparatus according to claim 49, wherein thecarrier signal is frequency, amplitude or frequency and amplitudemodulated.
 51. An apparatus according to claim 49, wherein the carriersignal is digital, analogue or digital and analogue.
 52. An apparatusaccording to claim 49, wherein the control signal used with the carriersignal is frequency, amplitude or frequency and amplitude modulated. 53.An apparatus according to claim 45, wherein the control signal comprisesa wave signal comprising one of a sound wave signal including anultrasound wave signal, an electromagnetic wave signal including aninfrared light signal, a visible light signal, an ultra violet lightsignal and a laser light signal, a micro wave signal, a radio wavesignal, an x-ray radiation signal, and a gamma radiation signal.
 54. Anapparatus according to claim 45, wherein the control signal comprises anelectric, magnetic or electric and magnetic field.
 55. An apparatusaccording to claim 45, wherein the control signal is digital, analogueor digital and analogue.
 56. An apparatus according to claim 55, whereinthe remote control transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signal.
 57. An apparatusaccording to claim 45, wherein the control signal is transmitted inpulses by the wireless remote control.
 58. An apparatus according toclaim 1, wherein the stimulation device is embedded in a soft orgel-like material.
 59. An apparatus according to claim 1, wherein thestimulation device is embedded in a silicone material having hardnessless than 20 Shore.
 60. An apparatus according to claim 1, wherein themuscle comprises the anal sphincter or extends around a portion of thebowels or rectus abdominis, the stimulation device comprises a band forapplication around the anal sphincter or the portion of the bowels orrectus abdominis, and the band is provided with the electric conductorsfor engaging the muscle.
 61. An apparatus according to claim 1, whereinthe electric conductors comprise hooks to secure the electric conductorson the muscle.
 62. An apparatus according to claim 61, wherein the hooksare to be inserted into the muscle.
 63. An intestine dysfunctiontreatment apparatus, comprising: an electric stimulation deviceimplantable in a patient, who suffers from intestine dysfunction,electric conductors of the electric stimulation device adapted todirectly engage with a muscle that is capable of contracting thepatient's large bowel in a wave-like manner for transporting the fecestherein, to electrically stimulate the muscle to increase the tonusthereof, an electric source of energy, and a control device controllablefrom outside the patient's body, wherein the control device is adaptedto control the stimulation device and the electric source of energy tomomentarily supply the stimulation device with electric energy to causethe muscle to momentarily contract the bowel in said wave-like manners,the electric source of energy releasing the electric energy in the formof an alternating current through the electric conductors, the intensityof the current through the electric conductors amounting to apredetermined value. the control device automatically controlling theelectric source of energy to release more electric energy to restore thepredetermined value of current intensity when the current through theelectric conductors decreases.
 64. An apparatus according to claim 63,wherein the control device is controllable by the patient to power thestimulation device to cause the muscle to contract the large bowel insaid wave-like manner, in order to avoid constipation.